LYNKUET

Elinzanetant C max and AUC increased in a greater than dose-proportional manner (20% to 50%) over the dose range from 40 to 160 mg once daily (0.33 to 1.33 times the highest recommended dose). Elinzanetant steady state plasma concentrations were reached in 5 to 14 days after daily dosing. Elinzanetant accumulation is <2-fold at the approved recommended dosage.

AbsorptionElinzanetant median (min-max) time to maximum plasma concentration (T max ) is 1.0 hours (1-2.5 hours) at steady state. Elinza...

14.1 Effects on Vasomotor Symptoms (VMS) in Postmenopausal Women The efficacy of LYNKUET for the treatment of moderate to severe vasomotor symptoms due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials. In OASIS 1 (NCT05042362) and OASIS 2 (NCT05099159), 796 menopausal women were randomized 1:1 to receive LYNKUET 120 mg or placebo once daily at bedtime for 12 weeks. In each of these two trials, after the first 12 weeks, women on placebo were switched over to LYNKUET and all women were then treated with LYNKUET f...

The following clinically significant adverse reactions are described elsewhere in the labeling: Central Nervous System (CNS) Depressant Effect and Daytime Impairment [see Warnings and Precautions (5.1) ] Hepatic Transaminase Elevations [see Warnings and Precautions (5.2) ] The most frequently reported (≥5%) adverse reactions were headache, fatigue, dizziness and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-...

LYNKUET is contraindicated in pregnancy. Exposure to LYNKUET may cause pregnancy loss or stillbirth when administered during pregnancy [see Use in Specific Populations (8.1 , 8.3) ] . Pregnancy. ( 4 )

CNS Depressant Effect and Daytime Impairment: Advise patients about the potential for somnolence and other nervous system effects. Advise patients who experience these effects to refrain from driving or engaging in hazardous occupations or activities until the effects have resolved ( 5.1 ) Hepatic Transaminase Elevations: Perform bloodwork prior to initiation of LYNKUET to evaluate for hepatic function and injury. Do not start therapy if serum transaminase concentration is equal to or exceeds tw...

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors and grapefruit (juice): Avoid concomitant use with LYNKUET. ( 7.1 ) Moderate CYP3A4 Inhibitors: Reduce LYNKUET dosage to 60 mg once daily. ( 2.2 , 7.1 ) Strong and Moderate CYP3A4 Inducers: Avoid concomitant use with LYNKUET. ( 7.1 ) 7.1 Effects of Other Drugs on LYNKUET Elinzanetant is primarily metabolized via CYP3A4 enzyme. Table 3 describes drug int...